It is the authorization granted by the health authority of a country after verifying compliance with legal-technical requirements, which empowers a natural or legal person to manufacture, import, store, distribute, market, promote, dispense, and/or sell products. The General Directorate of Medicines, Supplies, and Drugs (DIGEMID) is the entity responsible for granting sanitary registrations in Peru.

The validity of the sanitary registration for all pharmaceutical products or medical devices is five (05) years, counted from the date of issuance.

The re-registration application can be submitted starting ONE YEAR before the expiration of the sanitary registration.

Sanitary registrations can be requested by duly constituted companies such as: Drugstores or Laboratories.

A sanitary registration is granted by NAME, MANUFACTURER, COUNTRY, PHARMACEUTICAL FORM, QUANTITY OF ACTIVE PHARMACEUTICAL INGREDIENT (volume or dose).

It is an official document issued by the Competent Authority of the country of origin or exporter, based on the World Health Organization (WHO) model. It is exempted for products manufactured abroad under contract for a national laboratory or drugstore, which are not marketed in the manufacturing country (except for products under INN or, failing that, pharmacopeia, formulary, or reference supplement names, which may or may not be marketed in the manufacturing country) or manufactured domestically.

As of the application submission date, documents must be no older than two years, counted from the issuance date, unless the document specifies a different validity period.

The authorized pharmaceutical establishment (as a drugstore) may request a sanitary registration certificate. A registered pharmaceutical product or medical device may be imported and marketed by someone who is not the holder of the sanitary registration, provided it has the same characteristics as the product or medical device it references.

Within fifteen (15) days, DIGEMID issues a sanitary registration certificate for the pharmaceutical product or medical device in favor of the applicant.

Manufacturing (if a Laboratory), importation, storage, distribution, marketing, promotion, dispensing, sale, or use of the products.